Immunogenicity of a Trivalent Influenza Vaccine in Chronic Kidney Disease Patients Undergoing Hemodialysis

Korea University

Status and phase: Completed; Phase 4

Conditions: Chronic Kidney Disease; Influenza; End Stage Renal Failure

Treatments: Biological: Agrippal; Biological: Fluad

Study type: Interventional

Funder types: Other

Identifiers

NCT02686398

KUGH13170

Details and patient eligibility

About

During the 2013-2014 influenza season, CKD patients undergoing HD participated in the study. The patients were randomized into two groups (MF59-adjuvanted vaccine group or non-adjuvanted vaccine group) and were immunized with the respective vaccine. Sera were collected prior to vaccination and at 1and 6 months post vaccination. Levels of hemagglutination inhibition (HI) antibodies were measured.

Enrollment: 174 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic kidney disease patients undergoing hemodialysis
• Who have given written informed consent at the time of enrollment

Exclusion criteria

• Recipients of influenza vaccine of 2013-2014 season before the study
• History of egg allergy

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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174 participants in 2 patient groups

Fluad

Active Comparator group

Description:

88 CKD patients were vaccinated with Fluad.

Treatment:

Biological: Fluad

Agrippal

Active Comparator group

Description:

86 CKD patients were vaccinated with Agrippal.

Treatment:

Biological: Agrippal